title: Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial.
abstract: OBJECTIVE
  Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear.
  
  
  OBJECTIVE
  To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the intensive care unit (ICU) with hypovolemic shock.
  
  
  METHODS
  A multicenter, randomized clinical trial stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma). Therapy in the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial was open label but outcome assessment was blinded to treatment assignment. Recruitment began in February 2003 and ended in August 2012 of 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada; follow-up ended in November 2012.
  
  
  METHODS
  Colloids (n = 1414; gelatins, dextrans, hydroxyethyl starches, or 4% or 20% of albumin) or crystalloids (n = 1443; isotonic or hypertonic saline or Ringer lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay.
  
  
  METHODS
  The primary outcome was death within 28 days. Secondary outcomes included 90-day mortality; and days alive and not receiving renal replacement therapy, mechanical ventilation, or vasopressor therapy.
  
  
  RESULTS
  Within 28 days, there were 359 deaths (25.4%) in colloids group vs 390 deaths (27.0%) in crystalloids group (relative risk [RR], 0.96 [95% CI, 0.88 to 1.04]; P = .26). Within 90 days, there were 434 deaths (30.7%) in colloids group vs 493 deaths (34.2%) in crystalloids group (RR, 0.92 [95% CI, 0.86 to 0.99]; P = .03). Renal replacement therapy was used in 156 (11.0%) in colloids group vs 181 (12.5%) in crystalloids group (RR, 0.93 [95% CI, 0.83 to 1.03]; P = .19). There were more days alive without mechanical ventilation in the colloids group vs the crystalloids group by 7 days (mean: 2.1 vs 1.8 days, respectively; mean difference, 0.30 [95% CI, 0.09 to 0.48] days; P = .01) and by 28 days (mean: 14.6 vs 13.5 days; mean difference, 1.10 [95% CI, 0.14 to 2.06] days; P = .01) and alive without vasopressor therapy by 7 days (mean: 5.0 vs 4.7 days; mean difference, 0.30 [95% CI, -0.03 to 0.50] days; P = .04) and by 28 days (mean: 16.2 vs 15.2 days; mean difference, 1.04 [95% CI, -0.04 to 2.10] days; P = .03).
  
  
  CONCLUSIONS
  Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality. Although 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study before reaching conclusions about efficacy.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00318942.
authors.affiliation: Raymond Poincaré Hospital, Garches, France.
authors.forename: Djillali
authors.initials: D
authors.lastname: Annane
authors.forename: Shidasp
authors.initials: S
authors.lastname: Siami
authors.forename: Samir
authors.initials: S
authors.lastname: Jaber
authors.forename: Claude
authors.initials: C
authors.lastname: Martin
authors.forename: Souheil
authors.initials: S
authors.lastname: Elatrous
authors.forename: Adrien Descorps
authors.initials: AD
authors.lastname: Declère
authors.forename: Jean Charles
authors.initials: JC
authors.lastname: Preiser
authors.forename: Hervé
authors.initials: H
authors.lastname: Outin
authors.forename: Gilles
authors.initials: G
authors.lastname: Troché
authors.forename: Claire
authors.initials: C
authors.lastname: Charpentier
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Trouillet
authors.forename: Antoine
authors.initials: A
authors.lastname: Kimmoun
authors.forename: Xavier
authors.initials: X
authors.lastname: Forceville
authors.forename: Michael
authors.initials: M
authors.lastname: Darmon
authors.forename: Olivier
authors.initials: O
authors.lastname: Lesur
authors.forename: Jean
authors.initials: J
authors.lastname: Reignier
authors.forename: Jean
authors.initials: J
authors.lastname: Régnier
authors.forename: Fékri
authors.initials: F
authors.lastname: Abroug
authors.forename: Philippe
authors.initials: P
authors.lastname: Berger
authors.forename: Christophe
authors.initials: C
authors.lastname: Clec'h
authors.forename: Christophe
authors.initials: C
authors.lastname: Cle'h
authors.forename: Joël
authors.initials: J
authors.lastname: Cousson
authors.forename: Laure
authors.initials: L
authors.lastname: Thibault
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
mesh_terms: D000368:Aged; D003102:Colloids / Q000627:therapeutic use*; D016638:Critical Illness / Q000628:therapy*; D000077324:Crystalloid Solutions; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D007362:Intensive Care Units; D007552:Isotonic Solutions / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012121:Respiration, Artificial; D012769:Shock / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000627:therapeutic use
chemical_list: D003102:Colloids; D000077324:Crystalloid Solutions; D007552:Isotonic Solutions; D014662:Vasoconstrictor Agents